UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013627 |
|---|---|
| Receipt number | R000015898 |
| Scientific Title | Phase I/II trial of 5-FU, cisplatin, and weekly paclitaxel in patients with esophageal cancer |
| Date of disclosure of the study information | 2014/04/04 |
| Last modified on | 2019/02/15 18:31:47 |
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Basic information
Public title
Phase I/II trial of 5-FU, cisplatin, and weekly paclitaxel in patients with esophageal cancer
Acronym
Phase I/II trial of 5-FU, cisplatin, and weekly paclitaxel in patients with esophageal cancer
Scientific Title
Phase I/II trial of 5-FU, cisplatin, and weekly paclitaxel in patients with esophageal cancer
Scientific Title:Acronym
Phase I/II trial of 5-FU, cisplatin, and weekly paclitaxel in patients with esophageal cancer
Region
| Japan |
Condition
Condition
Esophageal cancer
Classification by specialty
| Gastroenterology | Hematology and clinical oncology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
A phase I/II study of a combination of triweekly FP(5-fluorouracil plus cisplatin) and weekly paclitaxel(PCF) is carried out to determine the maximum tolerated dose (MTD), recommended dose (RD), dose-limiting toxicities (DLTs) and objective response rate (RR) in patients with advanced or recurrent esophageal cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
Phase I
The maximum tolerated dose,recommended dose, and dose-limiting toxicities of weekly paclitaxel administration
Phase II
Response Rate of triweekly FP(5-fluorouracil plus cisplatin) and weekly paclitaxel (PCF).
Key secondary outcomes
Phase I
Adverse events, and response rate of PCF
Phase II
Curative setting group(potentially resectable)
Adverse events, pathological CR rate, progression free survival, and overall survival of PCF
Palliative setting group(potentially unresectable)
Adverse events, progression free survival, and overall survival of PCF
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
We add weekly paclitacel administration to triweekly 5-Fulorouracl 800mg/m2+ CDDP 80mg/m2. The starting dose of paclitaxel is 40mg/m2. If torelable, we increase doses of paclitaxel from 40mg/m2 to 60mg/m2. Next if tolerable, increase from 60mg/m2 to 80mg/m2.(the maximum dose)
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)A histologically confirmed
diagnosis of gastric, gastroesophageal, or esophageal carcinoma.
2) Clinical stage IB, II, III, and IV(UICC-TNM)
3) Age 18 to 75 years
4) Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
5) Previous chemotherapy is allowed, but limited only one resimen contained of platinum and the last chemotheapy was carried out in more than six months ago.
6) Sufficient organ function
7) Peripheral neuropathy less than CTCAE-Grade 1
8) Patients who provided written informed consent by themselves in principle to participate in this trial.
Key exclusion criteria
Poor control DM, active other cancer, the past history of hyper sensitivity of study drugs, active infection, continuous use of steroid, peripheral neuropathy greater than CTCAE-Grade 2, active interstitial pneumonia, pulmonary fibrosis, psychiatric disorder, cardiopulmonary disorder(past history of angina in less than 4 weeks, myocardial infarction in less than 6 monthes, poor control congenitive heart failure), untolerable alcohol
Target sample size
47
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masanori Watanabe |
Organization
Nippon Medical School Musashi Kosugi Hospital
Division name
Department of Gastrointestinal Surgery
Zip code
Address
1-396 Kosugi-chou, Nakahara-ku, Kawasaki city, Kanagawa, Japan
TEL
044-733-5181
margaux@nms.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoshi Nomura |
Organization
Nippon Medical School Musashi Kosugi Hospital
Division name
Department of Gastrointestinal Surgery
Zip code
Address
1-396, Kosugi-tyou, Nakahara-ku, Kawasaki city, Kanagawa, Japan
TEL
044-733-5181
Homepage URL
isonosan@nms.ac.jp
Sponsor or person
Institute
Nippon Medical School Musashi Kosugi Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
日本医科大学武蔵小杉病院
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 04 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 02 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 04 | Month | 04 | Day |
Last modified on
| 2019 | Year | 02 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015898
